The National Medical Products Administration (NMPA) in China has approved Qiagen’s QuantiFERON-TB Gold Plus (QFT-Plus) test for the detection of tuberculosis infection.
Qiagen stated that the latest development builds on QFT-Plus’ regulatory approvals for latent TB diagnosis in the US as well as other countries in the world.
The test is the fourth generation of the modern gold standard test for the detection of TB in China.
With 94% sensitivity and 97% specificity, it is now optimised with the addition of CD8 T cell technology, which helps to provide a more comprehensive view of the TB infection’s immune response.
Furthermore, the World Health Organization (WHO) has recommended the use of the company’s QIAreach QuantiFERON-TB (QIAreach QFT) test for additional research in more geographical and epidemiological settings.
Launched late last year, QIAreach QFT is a portable, battery-operated TB test that was recently approved by the Expert Review Panel Diagnostics (ERPD) of Global Fund.
The WHO’s continued recommendation will now allow public health programmes and institutions in more than 100 countries that qualify for Global Fund and/or UNITAID resources to procure the TB test.
QIAGEN Business Area Molecular Diagnostics senior vice-president Jean-Pascal Viola said: “The approval of the latest version of QuantiFERON TB-Gold Plus in China strengthens the global coverage that QIAGEN can offer in the fight against TB.
“The new WHO recommendation for IGRA tests also confirms the clinical performance and utility of IGRAs, and in particular the value of QFT-Plus as the modern gold standard for blood-based TB detection.
“Additionally, we are pleased that the WHO recognises the potential of QIAreach QFT to become a crucial element in TB detection strategies and our commitment to leave no country behind in this fight.”
Both QFT-Plus and QIAreach QFT are designed to detect interferon-gamma proteins released from T-cells that have had contact with TB bacteria in the blood.
Last December, Qiagen and Denovo Biopharma collaborated to develop a companion diagnostic (CDx) test to identify Diffuse Large B-Cell Lymphoma (DLBCL) patients expressing a biomarker.